Clinical Development

Regulatory Affairs

As your full-service regulatory affairs consulting partner, we deliver sound strategies and solutions to address your regulatory challenges.

Drive Your Products on the Right Track

Whatever your stage of clinical development, you need a trusted partner providing global regulatory affairs services to support your product. Tigermed’s consultants understand the importance of delivering sound global regulatory strategy and operational support for your products, and provide you with feasible approaches and act as a liaison with various regulatory agencies, both on technical and regulatory issues.

By continuously monitoring the global regulatory landscape and drawing on years of submission experience with NMPA, FDA and EMA, we can provide regulatory submission consulting across the full spectrum of activities and technical functions to stay ahead of any regulatory risks and keep your research on time and budget.

4,200+

Drug registration projects

1,000+

Global drug registration customers

Global Regulatory Affairs

IND & NDA Submission
CDE Communication Meeting Application
Submission Dossier Preparing
Gap Analysis
DMF/CEP Registration
Consulting Services
QC Testing Arrangement
Renew & Variation Application
Regulatory Strategy Development

Expertise. Strategy. Delivery.

Registration for Small Molecules

Global regulatory services for innovative drugs & generics in IND / CTA / NDA
Extensive experience in China NMPA registration and the regulations of FDA, EMA, and international regulatory authorities.

Global and Local Regulatory Insights

A team of nearly 60 seasoned experts providing life science regulatory intelligence and strategy, with profound insights into the regulatory reforms of the FDA, NMPA, and European healthcare authorities.

Registration for Biologics

NMPA IND and BLA for preventive and therapeutic biological products
FDA IND, ODD, RPDD for biologics
Global biotech regulatory strategy for multi-region clinical trials

Demonstrated Track Record

We have successfully supported thousands of regulatory approvals globally, including MRCT approvals of COVID-19 vaccines in Africa, Europe and APAC.

How We Ensure a Successful Submission for You

Our highly skilled team of global regulatory experts is devoted to providing regulatory strategy consulting and support for your drug or biological product at any stage of clinical development.
Internal supervision and control from PD with abundant project experience to ensure project quality.
Experiences from ongoing projects enable us to receive the first-hand intelligence and up-to-date regulatory trends from the drug authorities.
In-depth expertise on regulatory filing of both domestic & imported innovative drug.